AQUEOUS PHARMACEUTICAL COMPOSITION OF ANTIBODY TO PD-1 OF PROLGOLIMAB AND ITS USE Russian patent published in 2023 - IPC A61K39/395 A61K9/08 A61K47/12 A61K47/18 A61K47/26 A61P35/00 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions relates to aqueous pharmaceutical compositions for anti-PD-1 antibody prolgolimab, to the use of such pharmaceutical compositions and to a method of treatment using them. Variants of an aqueous pharmaceutical composition of anti-PD-1 antibodies are proposed, consisting of the following: prolgolimab as an antibody, trehalose dihydrate, sodium acetate trihydrate in certain amounts and acetic acid to provide pH in the range of 5.0–5.5; as well as variants of the aqueous pharmaceutical composition of anti-PD-1 antibodies, consisting of the following: prolgolimab as an antibody, trehalose dihydrate, L-histidine and L-histidine hydrochloride in certain amounts, at pH in the range of 5.5–6.0. The qualitative and quantitative composition of the excipients used in the composition variants ensures the stability of prolgolimab aqueous compositions in a wide range of its concentrations. Also provided is the use of the above variants of the aqueous pharmaceutical composition of the anti-PD-1 antibody of prolgolimab for the treatment of a malignant neoplasm, and a method for the treatment of a malignant neoplasm comprising administering a therapeutically effective amount of the variants of the above aqueous pharmaceutical composition.

EFFECT: obtaining aqueous pharmaceutical composition of antibody to PD-1 of prolgolimab.

58 cl, 23 tbl, 19 ex, 12 dwg